BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INTIMA-II Y 24GAX0.75IN PRN/EC SLM

    MDR report key: 20397262 · Received October 8, 2024

    Report

    Report Number
    3002601200-2024-00502
    Event Type
    Malfunction
    Date Received
    October 8, 2024
    Date of Event
    September 1, 2024
    Report Date
    October 15, 2024
    Manufacturer
    BD SUZHOU (MDS)
    Product Code
    FOZ
    UDI-DI
    00382903830336
    PMA / PMN Number
    UNK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    1. DHR/BHR REVIEW LOT#4080098. 1-THIS BATCH OF PRODUCTS WERE ASSEMBLED AT INTIMA II AUTO LINE 4 IN MARCH 2024, AND PACKAGED AT CFS PACKAGE LINE IN MARCH 2024. WORK ORDER QUANTITY WAS (B)(4) EA. 2-REVIEW THE IN-PROCESS TEST REPORTS AND OUTGOING TEST REPORTS, AND ALL TEST RESULTS MEET THE PRODUCT SPECIFICATIONS. 3-REVIEW THE PRODUCTION RECORDS WITH NO NONCONFORMANCE, DEVIATION OR REWORK ACTIVITIES. 4-REVIEW INCOMING INSPECTION RECORDS OF CATHETER, NO ABNORMALITIES. MATERIAL NUMBER: B5171AAAL, BATCH NUMBER:3360807, 3360806, 4022038, 4022054. 2. NO DEFECTIVE SAMPLES AND PHOTOS HAVE BEEN RECEIVED FOR THE COMPLAINT. 3. THE RETAINED SAMPLE OF THIS BATCH IS TAKEN FOR 45PSI LEAKAGE TEST AND CATHETER PULL FORCE TEST. THE TEST RESULTS SHOW THAT NO LEAKAGE IS FOUND AT THE CATHETER, AND THE CATHETER PULL FORCE IS WITHIN THE PRODUCT SPECIFICATIONS. PLEASE REFER TO THE ATTACHED TEST REPORTS. 4. DURING THE PUNCTURE, THE INDWELLING NEEDLE MAY BE PUNCTURED REPEATEDLY, CAUSING THE CATHETER TO BE PUNCTURED. 5. NO SIMILAR COMPLAINTS HAVE BEEN RECEIVED FROM OTHER HOSPITALS REGARDING THIS BATCH OF PRODUCTS. CONCLUSION(S): NO ABNORMALITIES ARE FOUND IN THE PROCESS AND RETAINED SAMPLE, AND NO SIMILAR COMPLAINTS HAVE BEEN RECEIVED FROM OTHER HOSPITALS REGARDING THIS BATCH OF PRODUCTS. BECAUSE THE DEFECTIVE SAMPLE HAS NOT BEEN RECEIVED, FURTHER INSPECTION CANNOT BE CARRIED OUT, AND THE ROOT CAUSE OF THE DISTORTED AND SEMI-BROKEN STATE OF THE CATHETER CANNOT BE CONFIRMED.

    Additional Manufacturer Narrative · 0

    H.3. IF A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION PROVIDED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD INTIMA-II Y 24GAX0.75IN PRN/EC SLM CATHETER KINK / BENT THE PATIENT WAS ADMITTED TO THE HOSPITAL ON (B)(6) WITH "POSTOPERATIVE INCISION INFECTION" DUE TO INCISION INFECTION AFTER HEPATIC LOBE SPECIAL SEGMENTAL RESECTION + CHOLECYSTECTOMY + PORTAL VEIN INCISION AND THROMBECTOMY AT (B)(6) UNIVERSITY, (B)(6), CHINA, ON (B)(6) 2024, AND WAS GIVEN ANTI-INFLAMMATORY AND REHYDRATION THERAPY BY THE NURSE USING AN INDWELLING NEEDLE, AND THE NURSE FOUND THE PATIENT'S MEDICATION NOT DRIPPING ON HER ROUNDS AND IMMEDIATELY CHECKED THE INDWELLING NEEDLE AND FOUND THAT THE TUBE OF THE INDWELLING NEEDLE WAS NOT CLEAR. ON THE MORNING OF SEPTEMBER 1, WHILE INFUSING THE SECOND BOTTLE OF FLUID, THE NURSE MADE ROUNDS AND FOUND THAT THE PATIENT'S MEDICATION WAS NOT DRIPPING, SO SHE IMMEDIATELY CHECKED THE INDWELLING NEEDLE AND FOUND THAT THE NEEDLE TUBE WAS NOT CLEAR. REMOVE THE NEEDLE AND CHECK, FOUND THAT THE SOFT CORE OF THE NEEDLE TWISTED AND FRACTURE, INCOMPLETE FRACTURE TO ABOUT 1/2, GIVEN TO REPLACE THE NEEDLE, AND RESET THE NEEDLE, INFUSION FLUIDS. EXPLAINED THE SITUATION AND THE PATIENT SHOWED UNDERSTANDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    52914 BD INTIMA-II Y 24GAX0.75IN PRN/EC SLM INTRAVASCULAR CATHETER FOZ BD SUZHOU (MDS) 4080098 00382903830336

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown